The following data is part of a premarket notification filed by G & W Applied Science Laboratories with the FDA for Help-mate.
Device ID | K813249 |
510k Number | K813249 |
Device Name: | HELP-MATE |
Classification | Hearing Aid, Air Conduction |
Applicant | G & W APPLIED SCIENCE LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-18 |
Decision Date | 1981-12-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HELP-MATE 80910400 0910400 Dead/Cancelled |
Ferguson Supply Ltd. 0000-00-00 |
HELP-MATE 78343118 not registered Dead/Abandoned |
Baughman, Karen A 2003-12-18 |
HELP-MATE 74259200 1843442 Dead/Cancelled |
Intervet, Inc. 1992-03-26 |
HELP-MATE 72345549 0902641 Dead/Expired |
MAIDENFORM, INC. 1969-12-08 |
HELP-MATE 72306188 0877291 Dead/Expired |
STRATHMORE PRODUCTS, INC. 1968-08-28 |